Add a sequence number to a randomization list

Sponsor users can now upload or generate a randomization list with a sequence number.

The sequence number option will assign the randomization numbers by sequence number, allowing for sounder blind study protection. Instead of assigning randomization numbers down the list (1001, 1042, 1203), now with the sequence number option the system will assign the randomization number according to the sequence number column (4, 50, 993), resulting in the randomization numbers being less predictable.

You can use the sequence number option when a study is being run for a very small set of subjects. It can add an additional layer of blinding, especially if you think a subject might be at risk of being unblinded.

Note:

The process applies to re-randomization and forced randomization.

There is no change in permissions to make use of this new feature. Users with the existing permission to Manage Randomization Lists can add and use sequence numbers for randomization.

Details for sponsor users

As a statistician, a clinical supply manager, or a sponsor user who manages randomization, here's what's new in your workflow:
  • When you generate a randomization list, or upload a randomization list, a new field for the sequence number is available:
    • If you upload a randomization list, a new option in Mapped to drop-down is available, giving you the option to map a column from the imported file to the sequence number. If you don't want to use this field, leave it empty.
    • When generating a randomization list, a new field called Starting Sequence Number is introduced on the List Settings view of the Generate Randomization List dialog. Use this field to set the sequence number you want the randomization list to start with. For example, you can start with number 90 or with number 1000.
  • When managing randomization lists, on the Manage Randomization Lists window, you can view the new Sorted by Sequence Number grayed-out title under the list name. This allows you to identify if randomization was done by sequence number.
  • When viewing the randomization list of an active study, on the Randomizations tab in the Supplies screen, a new column is available for the Sequence Number. If the sequence number option is not used, the column for it is not included in this table.

Impact on reports

Once this feature is available, you can find a new column for Sequence Number in the Randomization Report (Unblinded) report.

You can find additional information in the Sponsor and CRO User Guide and the Reporting Guide after the Release Assessment Environment (RAE) upgrade.

Parent topic: Randomization and trial supply management